Our Manufacturing
Every Strukmyer product begins inside our 30,000-square-foot facility in Mesquite, Texas. Here is what that means for the products you put on your skin and inside your home.
FDA-registered. Always.
Strukmyer holds FDA medical device facility registration and operates a 503B outsourcing facility. Every applicable product manufactured here is produced under cGMP (Current Good Manufacturing Practice) standards — the same framework that governs hospital and clinic supply.
ISO Class 8 cleanroom
Our wound care patches, hydrogel applicators and topical creams are filled in an ISO Class 8 cleanroom — a controlled environment with HEPA-filtered air, particulate monitoring, and full gowning protocols. The same standards used by pharmaceutical compounders.
Quality lab on-site
We do not outsource quality control. Every production batch is tested in our in-house quality lab — fill weight, microbial limits, label accuracy, packaging integrity. If a batch does not pass, it does not ship.
Made by a team that stays
Many of our production technicians have been here for over a decade. Their hands have packed millions of patches and bandages, and that experience shows in every box that leaves our dock.
Why direct-to-consumer?
For 14 years, Strukmyer made medical products for other brands — hospitals, healthcare distributors, and well-known consumer labels. We decided to sell directly because we believed three things:
- People deserve to know who manufactures the things they trust to their bodies.
- Skipping the middleman means lower prices for the same medical-grade quality.
- Made-in-USA medical manufacturing is worth keeping alive.
Certifications & recognition
- FDA-registered medical device facility
- 503B outsourcing facility registration
- cGMP compliant manufacturing
- ISO Class 8 cleanroom operations
- Inc. 5000 honoree, three consecutive years
- Member, Texas Manufacturers Association